Companion Diagnostics

Companion Diagnostic Assays with NanoString

Assay Development Options and Timelines

The increasing importance of incorporating companion diagnostic assays into therapeutic approaches has created a significant need for biomarker validation during earlier phases of drug development. Understanding the rich but complex maze of biomarker possibilities and distilling all of this into the most promising biomarker signature is essential.

Assay development and validation strategies for companion diagnostic assays all starts with a proven team. NanoString’s Companion Diagnostics Program is led by experienced experts who understand these considerations, and the value of planning a companion diagnostic strategy and path at an early stage of development.

1 – Prosigna Breast Cancer Prognostic Gene Signature Assay for use on the nCounter Dx Analysis System is 510(k) cleared for in vitro diagnostic use. See for Package Insert.

Building on the Discoveries of our Customers with NanoString as a Platform of Choice from Discovery to Diagnostic Assay

Publications are a great source of pride both for our customers and for NanoString. Each and every new publication brings exciting promise that together we are one step closer to addressing the complex challenges of treating and ultimately curing cancer.

The NanoString team provides a collection of some of the industry’s most capable and proven resources for the development of a Companion Diagnostic. With direct pharmaceutical and regulatory expertise, our collective knowledge spans throughout each step of the diagnostic process, creating a proven and productive cross-functional team.

  • Translational Research expertise to discover and optimize biomarker
  • Dedicated companion diagnostics research team, project managed under stringent design control guidelines.
  • Experience regulatory group knowledgeable on application and approval processes for IDE and PMA submissions.
  • Global clinical capability to execute clinical study protocols worldwide
  • Skilled commercial leadership with proven paths for reimbursement.
  • Meticulous manufacturing performed under ISO 13485 and GMP guidelines.

To speak with someone from NanoString’s Companion Diagnostics Program, please contact us at

Our Pipeline of New Diagnostic Assays Under Development

The nCounter portfolio of signatures is rapidly expanding as our system becomes more widely used. Signatures that started in the research lab, such as PAM 50 and work done by the Lymphoma/Leukemia Molecular Profiling Project (LLMPP) for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL), are powering companion diagnostic development, while many hundreds of publications with other cancer types are fueling future signature development.

Selected Signatures Developed with nCounter Technology

  • Subtypes of Diffuse Large B-cell Lymphoma
  • Prognosis in Hodgkin’s Lymphoma
  • Subtypes of Medulloblastoma
  • Transcriptional Signatures in Prostate Cancer
  • miRNA for Endometriosis and Ovarian Cancer

Other Sources of Content:

  • New biomarkers discovered with NSTG technology (customer code sets, panels, 3D biology)
  • Migration from other technology platforms (ie RNA seq, rtPCR, microarrays, etc),,, 4-These NanoString assays for use on the nCounter Dx Analysis System and are for investigational use only. Companion diagnostic products under development are for investigational use only. Limited by United States law to investigational use.